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Stent Implantation Versus Medical Therapy for Idiopathic IntracraniaL Hypertension (SIMPLE)

StatusRecruiting
PhasePhase 3
Started2023-02-16
View on ClinicalTrials.gov ↗

Amendment history

2026-02-08
Study Status, Eligibility v3
Primary completion date2026-06→2027-01
Completion date2026-12→2027-03
Start date2022-10-31→2023-02-16
Eligibility criteria+231 characters
Inclusion Criteria: Subject Eligibility Criteria Diagnosis of IIH by modified Dandy criteria about for more than 2 months Lumbar puncture opening pressure ≥250 [...] hunting, decompressive craniectomy or venous sinus stenting Progressive or rapid visual loss needed urgent surgical intervention; if delay>24-48 h consider interim lumbar drain (for rapid visual loss only).Surgical options to consider: CSF diversion or optic nerve sheath fenestration Visual loss due to other etiologies (eg, retinal drusen, ret [...]
2024-09-03
Study Status v2
Primary completion date2024-06→2026-06
Completion date2024-12→2026-12
2023-02-14
Active, Not Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusActive, Not Recruiting→Recruiting
Study sitesdetails revised at 1 of 1 site
2023-01-28
Original filing
The aim of this study is to assess the efficacy of stent implantation versus medical therapy on idiopathic intracranial hypertension with venous sinus stenosis.
Trial Details
NCT Number NCT05707442
Lead Sponsor Beijing Tiantan Hospital
Conditions Idiopathic Intracranial Hypotension, Venous Sinus Stenosis
Enrollment 74 participants
Start Date 2023-02-16
Primary Completion 2027-01 (estimated)
Study Completion 2027-03 (estimated)
Updated on ClinicalTrials.gov 2026-02-10